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After FDA refuses to act, data forces Bayer to remove drug from market

     The German manufacturer,  Bayer AG, recently removed Trasylol from the market after a Canadian study questioned its safety.  Trasylol had been approved by the FDA to enhance clotting and was used in a variety of situations, but particularly during open heart surgery.  Several recent studies had suggested that it carries a higher mortality rate than the cocktail of drugs used for this purpose previously, however, because the investigations were not done in classic "double-blind" methodology, the research is not clear-cut.   The most recent investigators felt, however, that it would be unethical to continue the study, given the developing findings suggesting that Trasylol patients were being exposed to an inappropriate and unjustifiable risk.   The FDA said it "could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks", which included heart attack, kidney failure and stroke.

        Despite removing the drug from the market, Bayer continues to claim that it is effective.  While the concerns about the drug were raised several months ago, the drug was never officially removed from approval by the FDA, despite two hearings on the subject.  The pro-manufacturer bias of the FDA process makes it very hard to remove any drug that has been granted approval in the past--no matter how little research preceded approval or what the subsequent research has shown.  At a hearing in September of 2007, medical witnesses and scientists called by Bayer to support Trasylol did not disclose that Bayer had conducted a test of its own which strongly suggested worrisome findings about its safety.  When the study was brought to light after Trasylol remained on the market, Bayer concluded that the findings had been withheld from the FDA as a result of "regrettable human error".  Of course, there were no negative consequences for Bayer as a result of this "error" and the drug remained on the market for two more months until a more definitive study increased the pressure on the manufacturer.

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